QCI
- Product code
- QCI
- Device name
- Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5802
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 9
FDA classification definition
External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K243459 | 2025-04-17 | Brain Ultimate, Inc. | Ultimate rTMS for OCD (M-series) summary |
| K230657 | 2024-02-01 | BTL Industries, Inc. | BTL-99-OC summary |
| K233742 | 2023-12-22 | Teleemg, LLC | CloudTMS Edge for OCD summary |
Official FDA classification page: QCI
Classification and pathway per current FDA publications. Data from openFDA (CC0).